The ASAC trial is a Scandinavian, multi-center, double-blinded, randomized,
placebo-controlled study to determine whether adjuvant treatment with low-dose
acetylsalicylic acid (ASA) can improve disease free survival in patients treated with
resection for colorectal cancer liver metastases (CRCLM).
Several studies have shown beneficial effect of ASA on primary prevention of CRC and the
investigators group and others have shown a potential association of ASA also taken after the
diagnosis on CRC survival in registry-based studies (secondary prevention). Up to 800
patients operated for CRCLM will be randomized to Arm#1 ASA 160 mg once daily or Arm#2
Placebo for a period of 3 years or till disease recurrence. The patients will be treated and
followed up according to standard of care and the National Guidelines.
The ASAC trial will be the first clinical interventional trial to assess the beneficial role
of ASA in recurrence of CRC liver metastases and survival. ASA is an inexpensive, well
tolerated, and easily accessible drug that will be highly potential as adjuvant drug in
secondary prevention of CRC liver metastases if the study shows a beneficial effect. This
trial will also investigate the effect of ASA as adjuvant treatment on Health-related Quality
of Life and the cost-effectiveness.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Oslo University Hospital
Collaborators:
Klinbeforsk Norwegian Cancer Society The Research Council of Norway